TECHNICAL FIELD
[0001] The invention relates to a stent graft, which can be used for treating the abdominal
aortic aneurysm.
BACKGROUND
[0002] At present, there are many kinds of stent grafts for treating the abdominal aortic
aneurysm and the iliac aneurysm on the market, and the various products have different
advantages and disadvantages, and have different treatment points. The stent graft
for treating the abdominal aortic aneurysm should mainly have the following characteristics:
the stent graft should be adapted to a bent tumor neck and a smaller tumor neck length,
should have comparatively good adhesion and roundness properties, should have comparatively
good bending properties, should have a moderate support strength, should be capable
of preventing a long-term displacement and the like.
[0003] At present, on the domestic and international markets, there are mainly the following
performance indexes to evaluate this kind of stent grafts: ① tightness: evaluating
the validity of the stent isolating the tumor cavity from the blood; ② anti-displacement:
preventing the displacement of the stent after the placement of the stent; ③ release
resistance: a proper release resistance being capable of smoothly releasing the stent
and avoiding the displacement of the stent; ④ positioning accuracy: evaluating the
degree of offset between the positioning before the release and the position of the
stent graft after the release; ⑤ stent flexibility: evaluating the ability of the
stent graft being adaptively bent in a bent blood vessel; ⑥ adaptation to a bent tumor
neck; and ⑦ a smaller tumor neck length.
[0004] Multiple stent grafts are disclosed in the prior art. For example, the patent document
EP2301476A1 discloses a suturing and knotting method for a stent graft, in which this knotting
method is used for fixing the stent section and the graft tube to prevent the displacement
of the stent graft after the stent graft is placed in the blood vessel, and this knotting
method can increase the pull-out force of the main stent graft and the branch stent
graft. In addition, the patent document
US2008/0114443A1 discloses a stent graft with its bare section carrying barbs and a proximal end structure
of a transport system for fixing the barbs, in which the bare section and the barb
are made by cutting.
[0005] Although the knotting method in the patent document
EP2301476A1 can improve the pull-out force, the knotting manner is complicated, the time is delayed,
and the production efficiency is comparatively low. In the solution of the patent
document
US2008/0114443A1, there are many barbs of the bare section, two barbs exist on one apex, the barbs
are close to each other, and the case that the blood vessel wall is torn and the like
may be caused after the placement in the blood vessel. Moreover, in the use of the
above stent grafts in the prior art, the positioning and suturing of the stent sections
are not convenient, and the bending and adhesion properties of the stent sections
are also to be further improved.
SUMMARY OF THE INVENTION
[0006] In view of the above technical problems in the prior art, the object of the invention
lies in developing a stent graft, which can buffer damages of the apexes of the stent
sections on the graft, facilitate positioning and suturing of the stent sections,
and improve bending and adhesion properties of the stent sections.
[0007] To be specific, the invention provides a stent graft, which comprises: a stent portion
including a bare section and a main section; and a graft tube fixed on the main section,
wherein the main section includes a plurality of stent sections along its axial direction,
characterized in that the stent graft (1) further comprises a plurality of circumferential
bosses (10) arranged on an outer circumference of the graft tube (11) along the axial
direction, and the circumferential bosses (10) and the stent sections (17) are alternately
arranged in the axial direction.
[0008] Preferably, the plurality of circumferential bosses are arranged on an outer circumference
of the graft tube at equal intervals in the axial direction.
[0009] Preferably, the outer diameter of the circumferential boss is larger than the outer
diameter of the graft tube by 1 mm-3 mm, and the width of the circumferential boss
is between 0.5 mm and 1.5 mm.
[0010] Preferably, the bare section includes a plurality of stent rods, which are formed
in a wavy structure, at least a part of the bare section is located outside the graft
tube, and the bare section further includes a shoulder (8) located at a position of
an intersection point of proximal ends of each two adjacent stent rods (6); a rear
release hole (9) connecting to a proximal end of each shoulder (8), the rear release
hole (9) being used for connecting the bare section (2) with a rear release device
of a stent transport system; and a barb (7) extending from each shoulder (8) toward
a distal end and being located between the corresponding two adjacent stent rods (6).
[0011] Preferably, the rear release hole is an elliptical-like hole, a round hole, a triangular
hole, a rectangular hole, a trapezoidal hole or a irregularly-shaped hole.
[0012] Preferably, in the case that the shape of the rear release hole is elliptical-like,
the rear release hole has a rear release hole length along the axial direction of
the stent graft and has a rear release hole width along a circumferential direction
of the stent graft, and the thicknesses of two outer walls of the rear release hole
in the circumferential direction of the stent graft plus the rear release hole width
is an outer profile width, wherein the rear release hole length is between 1.0 mm
and 4.0 mm, the rear release hole width is between 0.1 mm and 0.6 mm, and the outer
profile width is between 0.8 mm and 1.5 mm.
[0013] Preferably, in the case that the stent graft is in an expanded state, the diameter
of the proximal end portion of the bare section is larger than the diameter of the
distal end portion of the bare section.
[0014] Preferably, the thickness of the bare section is between 0.2 mm and 0.8 mm.
[0015] Preferably, the thickness of the bare section is between 0.4 mm and 0.6 mm.
[0016] Preferably, in the stent portion of the stent graft, only the bare section is a cut
stent section, and the other stent sections are all woven stent sections.
[0017] Preferably, the stent portion further includes at least two branch sections, and
proximal ends of the branch sections are connected with a distal end of the main section.
[0018] Preferably, the stent portion further includes a transition section, which is located
between the main section and the at least two branch sections and is used for transitioning
the main section to the at least two branch sections.
[0019] Preferably, the diameter of the proximal end portion of the transition section is
the same as the diameter of the distal end portion of the main section, and the transition
section tapers gradually from its proximal end portion to its distal end portion to
be perform a smooth transition to the at least two branch sections.
[0020] Preferably, the main section further includes a small wave section, which is arranged
close to the bare section.
[0021] Preferably, the waveform of the small wave section is designed as an equal-height
structure or a height-changing structure.
[0022] Preferably, the small wave section is made of filaments having a diameter of 0.2032-0.254
millimeter.
[0023] According to the invention, the stent graft is provided with the circumferential
bosses, which can buffer damages of the apexes of the stent sections on the graft,
facilitate positioning and suturing of the stent sections, and improve bending and
adhesion properties of the stent sections.
[0024] In addition, the transition section adopts a tapered transition shape, and thus can
effectively relieve the impact of the blood flow on the graft and the suture lines
in the area at the bifurcation; the bare section of the stent graft carries a barb,
which can prevent a long-term displacement after the implantation; the proximal end
portion of the stent graft is provided with a small wave section, which can improve
the adhesion and roundness properties; and with respect to the whole stent graft,
the other stent sections than the bare section are all made by weaving, which can
reduce the cost and improve the production efficiency.
BRIEF DESCRIPTION OF DRAWINGS
[0025] In order to illustrate the technical solutions of the embodiments of the invention
more clearly, the figures to be used in the descriptions of the embodiments will be
briefly introduced below. It is obvious that the figures in the descriptions below
are only some specific embodiments recorded in the present application, rather than
limitations of the scope of protection of the invention. Those skilled in the art
certainly can also obtain some other embodiments and figures according to these embodiments
and their figures of the invention without making inventive efforts.
Fig. 1 is a schematic diagram of the whole of the stent graft according to one embodiment
of the invention;
Fig. 2 is a plan view that shows the structure of the bare section of the stent graft
of the invention in an enlarged view;
Fig. 3 is a plan view that shows one structure of the rear release hole;
Fig. 4 is a plan view that shows the other structure of the rear release hole;
Fig. 5 is a schematic diagram of the spatial structure of the bare section after the
stent graft of the invention is implanted into the blood vessel of the human body
and the bare section is stereotyped;
Fig. 6 is a schematic diagram that shows the structure of the circumferential bosses
of the stent graft of the invention;
Fig. 7 is a schematic diagram of the stent graft with the circumferential bosses before
bending;
Fig. 8 is a schematic diagram of the stent graft with the circumferential bosses after
bending, wherein Fig. 8(a) shows the stent graft in a normal bending form, and Fig.
8(b) shows the stent graft in an ultimate bending form;
Fig. 9 is a schematic diagram that shows the small wave section having an equal-height
structure;
Fig. 10 is a schematic diagram that shows the small wave section having a height-changing
structure; and
Fig. 11 is an exploded detailed view of the transition section.
DETAILED DESCRIPTION
[0026] In order to make those skilled in the art better understand the technical solutions
in the present application, clear and complete descriptions of the technical solutions
in the embodiments of the invention will be given below by taking the figures in the
embodiments of the invention into consideration. It is obvious that the described
embodiments are only parts of the embodiments, rather than all of the embodiments,
of the present application. Based on the detailed embodiments of the present application
described below, all the other embodiments obtained by those skilled in the art without
making inventive efforts shall fall within the scope of the concept of the invention.
[0027] Fig. 1 is a schematic diagram of the whole of the stent graft 1 according to one
embodiment of the invention. The stent graft 1 of the invention comprises: a stent
portion 16 including a bare section 2 and a main section 15; and a graft tube 11 fixed
on the main section 15, wherein the main section 15 includes a plurality of stent
sections 17 along its axial direction, and the graft tube 11 is a tubular structure
formed of one or more layers of grafts. In the embodiment as shown in Fig. 1, the
stent portion 16 includes the bare section 2, the main section 15, a transition section
4 and two branch sections 5 in turn from the proximal end to the distal end of the
stent graft 1. The bare section 2 includes a plurality of first stent rods 6, which
are formed in a wavy structure, and at least a part of the bare section 2 is located
outside the graft tube 11. Each stent section 17 is annularly arranged around the
center axis of the stent graft 1. Each stent section 17 consists of a plurality of
second stent rods, i.e., the plurality of second stent rods form a ring around the
center axis of the stent graft 1 to form one stent section 17. The transition section
4 is located between the main section 15 and the branch sections 5 for transitioning
the main section 15 to the branch sections 5. In the embodiment in Fig. 1, only two
branch sections 5 of the stent graft are shown, but those skilled in the art should
understand that the invention can be also applied to a stent graft having more than
two branch sections. In addition, in the invention, the proximal end refers to the
end closer to the heart after the stent is implanted into the human body, and the
distal end refers to the end farther from the heart after the stent is implanted into
the human body. Specifically, in Fig. 1, the proximal end refers to the upper end
of the figure, and the distal end refers to the lower end of the figure.
[0028] In the stent graft 1 of the invention, in order to prevent a long-term displacement
of the stent graft, the bare section 2 at the proximal end of the stent graft is designed
as a bare stent structure with a barb 7. Fig. 2 is a plan view that shows the structure
of the bare section 2 of the stent graft 1 of the invention in an enlarged view. As
shown in Fig. 2, in addition to the first stent rods 6, the bare section 2 further
includes a rear release hole 9, a shoulder 8 and a barb 7, the shoulder 8 being located
at a position of an intersection point of proximal ends of two adjacent first stent
rods 6 and connecting the first stent rods 6 with the rear release hole 9, the rear
release hole 9 being used for connecting the bare section 2 with a rear release device
of a stent transport system (not shown), and the barb 7 extending from the shoulder
8 toward the distal end and being located between the two adjacent first stent rods
6. In Fig. 2, the proximal end refers to the right end of the figure, and the distal
end refers to the left end of the figure.
[0029] The proximal end of the bare section 2 is provided with the rear release hole 9,
and when the stent graft is released, a rear release device of a stent transport system
is used to release the stent graft 1, and the bare section 2 of the stent graft and
the rear release device are coupled to each other by a guide wire (not shown) in the
rear release device, wherein the guide wire is to pass through the above-described
rear release hole 9. The bare section 2 is a cut stent section.
[0030] The shoulder 8 of the bare section 2 is used for bearing forces applied from the
barb 7 and the rear release hole 9. After the release of the stent graft 1, the barb
7 penetrates into a good blood vessel wall of the human body by means of the tensile
force of the bare section 2 to thereby prevent the displacement of the stent graft.
The first stent rods 6 form a support structure of the whole stent graft.
[0031] Fig. 3 is a plan view that shows one structure of the rear release hole. As shown
in Fig. 3, the rear release hole 9 has an elliptical-like shape. Here, the term "elliptical-like
shape" is a common term in the art, and generally refers to a shape similar to the
elliptical shape, e.g., the shape shown in Fig. 3, and those skilled in the art can
clearly understand the meaning of this term. In Fig. 3, the rear release hole 9 has
a rear release hole length L1 along the axial direction of the stent graft and has
a rear release hole width L2 along the circumferential direction of the stent graft,
and the thicknesses of the two outer walls of the rear release hole 9 in the circumferential
direction of the stent graft plus the rear release hole width L2 is an outer profile
width L3. The rear release hole length L1 is preferably between 1.0 mm and 4.0 mm.
If the rear release hole length L1 is too short, the guide wire may be rendered severely
folded after the penetration of the guide wire, which results in that the later release
is incomplete or the guide wire cannot be withdrawn; and if the rear release hole
length L1 is too long, the length of the whole bare section 2 may be increased, which
results in that the lengths of the related components within the matched transport
system are increased, thereby increasing the length of the whole transport system.
The rear release hole width L2 is preferably between 0.1 mm and 0.6 mm. If the rear
release hole width L2 is too narrow, the diameter of the penetrated guide wire may
be rendered too thin, so each of the strength of the bare section 2 and the strength
of the penetrated guide wire is insufficient, so that the case that the release is
incomplete or the guide wire breaks during the release will occur; and if the rear
release hole width L2 is too wide, the whole profile of the stent graft may be rendered
increased, which results in that the stent graft cannot be mounted in the matched
transport system. The outer profile width L3 is preferably between 0.8 mm and 1.5
mm. If the outer profile width L3 is too narrow, the two outer walls of the rear release
hole 9 in its transvers direction may be rendered too thin, so the risk of break is
likely to occur; and if the outer profile width L3 is too wide, the whole profile
of the stent graft may be rendered increased, which results in that the stent graft
cannot be mounted in the matched transport system.
[0032] Fig. 4 is a plan view that shows the other structure of the rear release hole. A
shown in Fig. 4, the rear release hole 9 has a substantially triangular shape. In
addition, according to the consideration of the different types and the whole performance
of the rear release device, the rear release hole 9 can be also a rectangular hole,
a round hole, a trapezoidal hole or a irregularly-shaped hole. The term "irregularly-shaped
hole" is a common technical term in the art, and generally refers to a hole different
from that of a general type or pattern, e.g., holes having some other irregular shapes
than an elliptical-like shape, a round shape, a triangular shape, a rectangular shape
and a trapezoidal shape.
[0033] Fig. 5 is a schematic diagram of the spatial structure of the bare section after
the stent graft of the invention is implanted into the blood vessel of the human body
and the bare section is stereotyped. As shown in Fig. 5, after the stent graft 1 is
implanted into the blood vessel and the bare section 2 is stereotyped, i.e., in the
case that the stent graft 1 is in an expanded state, the bare section 2 forms a ring,
and the diameter D1 of the proximal end portion of the bare section 2 is larger than
the diameter D2 of the distal end portion of the bare section 2, which facilitates
the penetration of the barb 7 into the blood vessel after the stent graft 1 is released
from the transport system and opened smoothly to thereby prevent the displacement
of the stent graft 1. As shown in Fig. 5, the thickness T1 of the bare section 2 is
between 0.2 mm and 0.8 mm, preferably between 0.4 mm and 0.6 mm. If the thickness
T1 of the bare section 2 is too thin, the support strength of the bare section 2 will
be rendered comparatively weak; and if the thickness T1 of the bare section 2 is too
thick, the bare section 2 will be rendered too thick or too hard to thereby result
in that the stent graft cannot be opened, and the whole profile of the stent will
be rendered increased, which results in a comparatively difficult assembly. It should
be noted that in Fig. 5, the thickness of the bare section 2 refers to the thickness
size of the bare section 2 in the radial direction of the stent graft 1, the proximal
end refers to the upper end of the figure, and the distal end refers to the lower
end of the figure.
[0034] Fig. 6 is a schematic diagram that shows the structure of the circumferential bosses
of the stent graft of the invention. As shown in Fig. 1 and Fig. 6, in the stent graft
1, a plurality of circumferential bosses 10 integrated with the graft tube 11 are
formed (three circumferential bosses are shown in the embodiments in Fig. 1 and Fig.
6) outside the graft tube 11, namely the material of the circumferential bosses 10
is the same as the material of the graft tube 11, both of which are flexible materials.
Each of the plurality of circumferential bosses 10 extends around the outer circumferential
surface of the graft tube 11 in the circumferential direction and protrudes towards
the outer side of the graft tube 11. The circumferential bosses 10 and the stent sections
17 of the main section 15 are alternately arranged in the axial direction of the main
section 15. Preferably, the plurality of circumferential bosses 10 are arranged on
the outer circumference of the graft tube 11 at equal intervals in the axial direction
of the main section 15. But, those skilled in the art can understand that in some
other embodiments of the invention, the spacing distances between the plurality of
circumferential bosses 10 may be also not equal.
[0035] The circumferential bosses 10 outside the graft of the invention have the following
characteristics:
① Relieving the fatigue wear of the apex of the stent section
[0036] When the stent graft is axially compressed, if there are no circumferential bosses
10, the compressions between the stent sections 17 will be irregular, and since the
support strength of the stent section is large, the impact of the apex of the stent
section on the graft(s) of the graft tube 11 is comparatively strong, and a long-term
wear may result in that the apex of the stent section bursts the graft, thus the stent
graft may be rendered leaky; and after the addition of the circumferential bosses
10, the whole stent graft will be compressed along the trace of the circumferential
bosses 10 after the stent graft is applied by an axial compression force, so the wear
of the stent graft by the apex of the stent section may be relieved.
② Adding adhesion properties
[0037] After the stent graft is implanted into the human body, the case that there is a
plaque on the blood vessel wall at the implantation site may be encountered, and after
the part having a metal stent meets the plaque, adverse consequences such as a bad
adhesion and an internal leakage are likely resulted in. In contrast, after the stent
graft 1 with the circumferential bosses 10 of the invention is implanted into the
blood vessel tumor cavity, along with the impact of the blood flow, the contact of
the graft material of a circumferential boss structure with the blood vessel wall
will be increased, so the adhesion properties of the whole stent graft may be increased
and the internal leakage may be reduced.
③ Facilitating bending and increasing smoothness of the blood flow
[0038] The stent graft 1 of the invention is provided with a plurality of circumferential
bosses 10, so the whole of the stent graft 1 is bent along with the shape of the circumferential
bosses 10 when the stent graft 1 is bent. Thus, the bending properties of the whole
of the stent graft may be increased after the suturing of the stent sections.
[0039] Generally, the outer diameter W2 of the circumferential boss 10 is larger than the
outer diameter W1 of the graft tube 11 of the stent graft 1 by 1 mm-3 mm (see Fig.
6), and the width H1 of the circumferential boss 10 is between 0.5 mm and 1.5 mm.
If the width H1 of the circumferential boss 10 is too narrow, the circumferential
boss 10 may be rendered unable to effectively reduce the wear between the stent section
and the graft and achieve the effect of bending flexibility; and if the width H1 of
the circumferential boss 10 is too wide, the interval between the stent sections may
be rendered too large, which, on the contrary, is more likely to cause folding. Here,
the outer diameter of the circumferential boss 10 refers to the diameter of the outermost
part of the circumferential boss 10 extending around the center axis of the stent
graft 1, and the width of the circumferential boss 10 refers to the axial size of
the circumferential boss 10 measured along the center axis of the stent graft 1.
[0040] The forms of the stent graft 1 with the circumferential bosses 10 before and after
bending are shown in Fig. 7 and Fig. 8. Fig. 7 is a schematic diagram of the stent
graft with the circumferential bosses 10 before bending, wherein the graft tube of
the stent graft is straight. Fig. 8 is a schematic diagram of the stent graft with
the circumferential bosses 10 after bending, wherein the graft tube of the stent graft
1 is bent, wherein Fig. 8(a) shows the stent graft 1 in a normal bending form, and
Fig. 8(b) shows the stent graft 1 in an ultimate bending form.
[0041] As shown in Fig. 7 and Fig. 8, when the graft tube 11 with the circumferential bosses
10 is bent, the graft tube 11 will be bent along the trace of the circumferential
bosses, and along with the increase of the bending degree, the lesser bending side
(the left side in Fig. 8(b), i.e., the inner side of the bent part) of the bending
of the circumferential boss 10 is compressed, and the upper edge and lower edge in
the circumferential boss 10 contact with each other along with the deepening of the
bending degree, as shown in Fig. 8(b), in which case since the circumferential bosses
10 are located at the outer side of the whole stent graft, they will not influence
the blood flow; and the greater bending side (the right side in Fig. 8(b), i.e., the
outer side of the bent part) of the bending of the circumferential boss 10 will be
completely expanded to facilitate the increase of its bending amount. If there are
no circumferential bosses 10, in the case that the greater bending side of the graft
is completely expanded, the graft at the lesser bending side will be inevitably wrinkled,
and the wrinkle inside the stent graft will influence the speed of the blood flow.
In contrast, in the invention, with respect to the lesser bending side with the circumferential
bosses 10, along with the increase of the bending degree, the upper edge and lower
edge in the circumferential boss 10 at the lesser bending side will contact with each
other, and the other grafts are supported by the stent sections, so no excess wrinkles
will be produced in the internal grafts to influence the blood flow.
④ Accurately positioning the stent sections
[0042] The addition of the circumferential bosses 10 may facilitate the positioning of the
stent sections and facilitate precise suturing, so that the practicability of the
suturing process is greatly increased.
[0043] All the stent sections for treating the abdominal aortic aneurysm have comparatively
large diameters, a large-scale cutting machine is comparatively expensive, and some
after-treatment operations, e.g., polishing, stereotyping, sand blasting, or other
subsequent processing operations, are to be performed after the cutting of the stent
sections, so the price for cutting the stent sections is high. The woven stent sections
can stereotype the desired outlines of the stent sections only by various weaving
and stereotyping molds, i.e., the adoption of the woven stent sections can both reduce
the cost and ensure the same performance. In the stent graft 1 of the invention, it
is allowed to form only the bare section 2 into a cut stent section and form all the
other stent sections, including but not limited to the aforementioned wave section
3 and stent section 17, as well as the sections in the branch sections 5 and the central
structure of the transition section to be mentioned below, into woven stent sections,
thereby reducing the cost.
[0044] As shown in Fig. 1, the stent portion 16 further includes at least two branch sections
5, and the proximal ends of the branch sections 5 are connected with the distal end
of the main section 15. The stent portion 16 further includes a transition section
4, which is located between the main section 15 and the branch sections 5 and is used
for transitioning the main section 15 to the branch sections 5. The design of the
transition section 4 in the stent portion 16 of the stent graft is as shown in Fig.
11. Fig. 11 is an exploded detailed view of the transition section 4. Since the diameter
of the main section 15 of the stent graft 1 is comparatively large, and the diameter
of the branch section 5 is comparatively small, if the connection is directly made
from the main section of the stent graft 1 to the branch sections, the impact of the
blood flow on the graft at the connection section, especially the graft at the bifurcation
and the neighboring suture lines, will be very large, which will result in that the
graft in the area at the bifurcation is severely impacted by the blood flow to be
damaged, and which will result in a severe wear at the suture of the main section
and the first section of the stent sections of the branch sections, so the stent sections
may drop or leakage of blood may occur at the bifurcation, and thereby cause a severe
result.
[0045] With respect to the above problem, the invention designs a transition section 4,
which can smoothly and stably transition the part having a large diameter of the stent
graft at the proximal end to the parts having small diameters of the two branch sections
at the distal end. As shown in Fig. 1 and Fig. 11, the diameter of the proximal end
portion 12 of the transition section 4 is the same as the diameter of the distal end
portion of the main section 15, and the transition section 4 tapers gradually from
its proximal end portion 12 to its distal end portion 14 to perform a smooth transition
to the two branch sections 5, where the reference sign 13 denotes a central structure
of the transition section. It should be noted that in Fig. 11, the proximal end refers
to the upper end of the figure, and the distal end refers to the lower end of the
figure. By the above design of the invention, the influence of the impact of the blood
flow on the stent graft can be reduced after the whole stent graft is implanted.
[0046] In the invention, a small wave section 3 having a woven structure can increase the
adhesion and roundness properties of the proximal end of the stent graft. As shown
in Fig. 1, the main section 15 can further include a small wave section 3, which is
arranged close to the bare section 2. In Fig. 1, the small wave section 3 is located
at the edge portion the proximal end of the graft tube 11 formed of the graft material.
The small wave section 3 is used for improving the adhesion properties of the proximal
end of the stent graft and preventing the generation of the internal leakage. The
waveform structure of the small wave section 3 is dimensionally smaller than the waveform
structures of the other stent sections in the stent portion 16. The waveform of the
small wave section 3 can be designed as an equal-height structure or a height-changing
structure. The filament diameter of the small wave section is comparatively thin.
The structure of the small wave section is as shown in Fig. 9 and Fig. 10. Fig. 9
is a schematic diagram that shows the small wave section 3 having an equal-height
structure. The small wave section 3 has an equal-height structure, i.e., the structure
in which all the upper apexes are on the same plane, all the lower apexes are on the
other same plane, and the respective stent rods have the same length is called an
equal-height structure. Fig. 10 is a schematic diagram that shows the small wave section
3 having a height-changing structure. In the height-changing structure of the small
wave section 3 shown in Fig. 10, all the upper apexes are on the same plane, but not
all the lower apexes are on the other same plane, and this height-changing structure
having apexes being not on the same plane facilitates reduction of the profile of
the whole stent graft.
[0047] Since the function of the small wave section 3 is to increase the adhesion and roundness
properties, the filament diameter of the small wave section 3 is selected to be comparatively
thin, and a filament diameter of 0.2032-0.254 millimeter (0.008-0.010 inch), which
is greatly smaller than the filament diameter of the stent sections of the main section,
is generally selected.
[0048] The stent graft of the invention is adapted to treat the abdominal aortic aneurysm.
During the operation, the stent graft is released after being guided to the lesion
site, the stent made of metal material supports the graft material on the normal blood
vessel walls at the both ends of the diseased blood vessel, so that the stent graft
isolates the aneurysm from the blood flow within the blood vessel cavity to thereby
eliminate the risk of break of the blood vessel and achieve the object of maintaining
the blood flow of the aorta smooth; and the outer wall of the blood vessel is retracted
due to the negative pressure, the normal blood vessel shape can be slowly restored,
and the vascular intima cells permeate the micropores in the graft material and finally
completely cover the stent graft to achieve endothelialization of the stent graft.
Moreover, the invention can be applied to the cases of the abdominal aortic aneurysm
involving a short tumor neck and a bent tumor neck, i.e., the stent graft of the invention
is more suitable for a comparatively short tumor neck length and a tumor neck that
is bent more, has better adhesion and roundness properties, has a moderate support
strength, can prevent a long-term displacement of the stent graft after the implantation
of the stent graft and the like.
[0049] As compared with the stent grafts in the prior art, the stent graft of the invention
has the following advantageous technical effects:
- 1. The stent graft is provided with the circumferential bosses, which can buffer damages
of the apexes of the stent sections on the graft, facilitate positioning and suturing
of the stent sections, and improve bending and adhesion properties;
- 2. The transition section adopts a tapered transition shape, and thus can effectively
relieve the impact of the blood flow on the graft and the suture lines in the area
at the bifurcation;
- 3. The bare section of the stent graft carries a barb, which can prevent a long-term
displacement after the implantation;
- 4. The proximal end portion of the stent graft is provided with a small wave section,
which can improve the adhesion and roundness properties; and
- 5. With respect to the whole stent graft, the other stent sections than the bare section
are all made by weaving, which can reduce the cost and improve the production efficiency.
[0050] The stent graft of the invention can meet the various performance indexes to evaluate
this kind of stent grafts as mentioned above in the Description, i.e., the stent graft
has a very good tightness and thus can isolate the tumor cavity from the blood; the
bare section carries a barb, and thus can prevent the displacement of the stent after
the implantation of the stent; the adoption of a proper release resistance can smoothly
release the stent and avoid the displacement of the stent; the rear release function
of the stent can accurately position the stent graft; the stent graft has a comparatively
low edge height and thus has a good flexibility; and the stent graft can be adapted
to a smaller tumor neck length. To sum up, the invention can be adapted to various
types of abdominal aortic aneurysms.
[0051] The above contents are only some detailed embodiments of the present application.
It should be noted that those skilled in the art can also make various combinations
or make some improvements and variations with respect to the above embodiments in
the case of not breaking away from the inventive principle and inventive concept of
the present application, and these combinations, improvements and variations should
be also deemed as ones falling within the scope of protection and the inventive concept
of the present application.
1. A stent graft (1), comprising: a stent portion (16) including a bare section (2) and
a main section (15); and a graft tube (11) fixed on the main section (15), wherein
the main section (15) includes a plurality of stent sections (17) along its axial
direction,
characterized in that
the stent graft (1) further comprises a plurality of circumferential bosses (10) arranged
on an outer circumference of the graft tube (11) along the axial direction, and the
circumferential bosses (10) and the stent sections (17) are alternately arranged in
the axial direction.
2. The stent graft (1) according to claim 1, characterized in that the plurality of circumferential bosses (10) are arranged on an outer circumference
of the graft tube (11) at equal intervals in the axial direction.
3. The stent graft (1) according to claim 1 or 2, characterized in that an outer diameter (W2) of the circumferential boss (10) is larger than an outer diameter
(W1) of the graft tube (11) by 1 mm-3 mm, and a width (H1) of the circumferential
boss (10) is between 0.5 mm and 1.5 mm.
4. The stent graft (1) according to claim 1 or 2,
characterized in that:
the bare section (2) includes a plurality of stent rods (6), which are formed in a
wavy structure, at least a part of the bare section (2) is located outside the graft
tube (11), and the bare section (2) further includes:
a shoulder (8) located at a position of an intersection point of proximal ends of
each two adjacent stent rods (6);
a rear release hole (9) connecting to a proximal end of each shoulder (8), the rear
release hole (9) being used for connecting the bare section (2) with a rear release
device of a stent transport system; and
a barb (7) extending from each shoulder (8) toward a distal end and being located
between the corresponding two adjacent stent rods (6).
5. The stent graft (1) according to claim 4, characterized in that the rear release hole (9) is an elliptical-like hole, a round hole, a triangular
hole, a rectangular hole, a trapezoidal hole or a irregularly-shaped hole.
6. The stent graft (1) according to claim 5, characterized in that in the case that the shape of the rear release hole (9) is elliptical-like, the rear
release hole (9) has a rear release hole length (L1) along the axial direction of
the stent graft and has a rear release hole width (L2) along a circumferential direction
of the stent graft, and the thicknesses of two outer walls of the rear release hole
(9) in the circumferential direction of the stent graft plus the rear release hole
width (L2) is an outer profile width (L3), wherein the rear release hole length (L1)
is between 1.0 mm and 4.0 mm, the rear release hole width (L2) is between 0.1 mm and
0.6 mm, and the outer profile width (L3) is between 0.8 mm and 1.5 mm.
7. The stent graft (1) according to claim 1 or 2, characterized in that in the case that the stent graft (1) is in an expanded state, the diameter (D1) of
the proximal end portion of the bare section (2) is larger than the diameter (D2)
of the distal end portion of the bare section (2).
8. The stent graft (1) according to claim 1 or 2, characterized in that the thickness (T1) of the bare section (2) is between 0.2 mm and 0.8 mm.
9. The stent graft (1) according to claim 8, characterized in that the thickness (T1) of the bare section (2) is between 0.4 mm and 0.6 mm.
10. The stent graft (1) according to claim 1 or 2, characterized in that in the stent portion (16) of the stent graft (1), only the bare section (2) is a
cut stent section, and the other stent sections are all woven stent sections.
11. The stent graft (1) according to claim 1 or 2, characterized in that the stent portion (16) further includes at least two branch sections (5), and proximal
ends of the branch sections (5) are connected with a distal end of the main section
(15).
12. The stent graft (1) according to claim 11, characterized in that the stent portion (16) further includes a transition section (4), which is located
between the main section (15) and the at least two branch sections (5) and is used
for transitioning the main section (15) to the at least two branch sections (5).
13. The stent graft (1) according to claim 12, characterized in that the diameter of the proximal end portion (12) of the transition section (4) is the
same as the diameter of the distal end portion of the main section (15), and the transition
section (4) tapers gradually from its proximal end portion (12) to its distal end
portion (14) to perform a smooth transition to the at least two branch sections (5).
14. The stent graft (1) according to claim 1 or 2, characterized in that the main section (15) further includes a small wave section (3), which is arranged
close to the bare section (2).
15. The stent graft (1) according to claim 14, characterized in that the waveform of the small wave section (3) is designed as an equal-height structure
or a height-changing structure.
16. The stent graft (1) according to claim 14, characterized in that the small wave section (3) is made of filaments having a diameter of 0.2032-0.254
millimeter.